RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD

RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD is an FDA 510(k)-cleared medical device (K955801) manufactured by Terumo Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 1, 1996. Regulation: 8.